司普奇拜单抗治疗慢性鼻窦炎伴鼻息肉的疗效:基于生物标志物的亚组分析OA

OBJECTIVE Aimed to evaluate the efficacy of stapokibart in patients with CRSwNP stratified by baseline inflammatory biomarker levels.METHODS This post hoc analysis was based on data from the multicenter,randomized,double-blind,placebo-controlled phase 3 CROWNS-2 study.Patients were stratified according to baseline biomarker levels,including peripheral blood and tissue eosinophil counts,serum total immunoglobulin E,serum thymus and activation-regulated chemokine,and plasma eotaxin-3 levels.The efficacy of stapokibart was assessed across different biomarker-defined subgroups.RESULTS In subgroups stratified by the median baseline level of each biomarker,stapokibart significantly reduced nasal polyp scores compared with placebo after 24 weeks of treatment[all P values(vs.placebo)<0.0001].In addition,stapokibart significantly improved symptom-related outcomes,including nasal congestion,loss of smell,University of Pennsylvania smell identification test scores,and total nasal symptom scores,as well as Lund-Mackay CT scores and quality-of-life scores,compared with placebo across all biomarker subgroups[all P values(vs.placebo)<0.05].In terms of the onset of action,clinical responses were observed earlier in patients with higher baseline biomarker levels,whereas patients with lower baseline levels experienced a relatively delayed onset but still achieved significant clinical benefits.CONCLUSION Stapokibart provides significant clinical benefits for patients with CRSwNP across different biomarker levels.The onset of action is associated with biomarker levels,suggesting that biomarkers may help guide individualized treatment.